Crystalline and pure modafinil, and process of preparing the...

Details Crystalline and pure modafinil, and process of preparing the... Crystalline and pure modafinil, and process of preparing the...

C - Chemistry, Metallurgy

07

C

C07C 317/44 (2006.01) C07C 315/06 (2006.01)

Patent

CA 2634702

The present invention provides an improved process for preparing modafinil, whereby it may be isolated in high purity by a single crystallization. The process produces modafinil free of sulphone products of over-oxidation and other byproducts. The invention further provides new crystalline Forms II-VI of modafinil and processes for preparing them. Each of the new forms is differentiated by a unique powder X-ray diffraction pattern. The invention further provides pharmaceutical compositions containing novel modafinil Forms II-IV and VI.

La présente invention porte sur un procédé de préparation amélioré du modafinil, dans lequel il est isolé par une seule cristallisation qui donne lieu à un produit d'une grande pureté. Le procédé aboutit à du modafinil sans produits sulfonés provenant d'un excès d'oxydation et sans autres sous-produits. L'invention concerne aussi de nouvelles formes cristallines de modafinil, les formes II-VI, et des procédés de préparation de ces formes. Chacune de ces nouvelles formes se distingue par son profil de diffraction aux rayons X unique, réalisé avec le produit sous forme de poudre. L'invention se rapporte aussi à des compositions pharmaceutiques contenant les nouvelles formes de modafinil, soit les formes II-IV et VI.

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